SPRINTT

Sarcopenia and physical frailty in older people: multi‐component treatment strategies

Summary

Europe’s population is becoming frail and less mobile as it ages, leaving us prone to accident and lifelong disability or reduced mobility. The SPRINTT project set out to better understand the problem of physical frailty and sarcopenia (muscle wasting), hoping that a clear and usable definition of the condition will help identify the exact target population that requires attention to avoid this fate. They set up a clinical trial with over 1,500 people to evaluate the effectiveness of a multi-component intervention at preventing mobility disability in an older population at risk of disability. They also designed a study to identify and validate diagnostic and prognostic biomarkers for physical frailty & sarcopenia.

Background

Older people with physical frailty and sarcopenia are more vulnerable to mobility limitations and disability. Frail older people are also more likely to be hospitalised or to require long-term care in a nursing home. Yet, despite the devastating impact this condition has on older people's quality of life and the sustainability of healthcare systems, there is no formal, widely-accepted definition of frailty and no treatment to prevent its onset and progression. The SPRINTT project set out to define the specific characteristics of physical frailty and sarcopenia that can be easily applied in healthcare settings and to carry out a large clinical trial to assess treatment options designed to prevent loss of mobility.

Vulnerable population

The SPRINTT consortium demonstrated the existence of a specific population of vulnerable older adults at risk of negative outcomes. The operational definition of physical frailty and sarcopenia (PF&S) developed by the project members intercepts older adults in a critical but still reversible step of the disabling cascade. At this stage, different interventions (whether lifestyle modifications, pharmacologic strategies, or a combination) may be put in place to preserve mobility and, therefore, an independent lifestyle for a large share of older adults.

People with PF&S may be easily spotted in everyday life and the SPRINTT researchers developed an easy‐to‐use identikit to find them in the community. A prototypical person with PF&S is an old person who walks at a slow pace and who may or may not use a cane. They may need help rising from a chair, and they often hold the handrails while walking up and down stairs. People with PF&S may be overweight or underweight but have a low muscle function that impairs their way of moving freely and enjoying their life.

Unwittingly, people with PF&S are at high risk of incurring medical problems that may lead to hospitalisation or institutionalisation and require care, which makes them a subset of the older population with unmet medical needs. The defining criteria of PF&S are objective and measurable; in particular, the physical function domain of PF&S is assessed through the use of what’s known as the short physical performance battery (SPPB), a well‐known, standardised, easy‐to‐apply and highly reproducible set of functional tests.

The European Medicines Agency identified the SPPB as the preferred option to characterise functional performance and physical frailty in clinical trials in vulnerable older adults. It has a “prognostic value of disability and mortality; validation status; feasibility of use across all therapeutic areas; ease of use; time required; ease of investigator’s training; cost” that make the SPPB a full‐fledged functional biomarker of ageing.

Trial

The SPRINTT trial screened thousands of people and enrolled 1,519 people from 11 countries from across Europe, who were then randomly allocated to one of two groups. They tested the effects of a multicomponent intervention (MCI), based on physical activity, nutritional counselling, and information and communication technology solutions, in community‐dwelling older persons with PF&S in comparison with a healthy ageing lifestyle education (HALE) programme for preventing mobility disability. All participants were followed for at least two years.

Ultimately, they were able to show that a working definition of PF&S is possible, that the people in question are identifiable in the community, and finally, that something can be done to help them.

The trial demonstrated that a multimodal non-pharmacological intervention with diet and exercise really does work to prevent the development of mobility disability. This goes against a commonly held belief that this condition is an inevitable by-product of ageing and offers a lot of hope. According to the project coordinators, people not only benefitted from increased health and strength as a result of the interventions in the trial, but emotionally, too. The results of the SPRINTT trial are summarised in an article that has been accepted for publication in the prestigious British Journal of Medicine.

Legacy

The project team will work closely with medicines regulators to ensure its findings can be rapidly implemented and applied to improve the development of innovative drugs for frailty. Ultimately, the outcomes of the SPRINTT project should result in improved treatment options and a better quality of life for the frail. Pharmaceutical industries and SMEs will also benefit from the project that established sound methodologies for developing innovative treatments for frailty and sarcopenia. A community was built around the project of adults enrolled in the trials that continues to thrive.

 

 

Achievements & News

SPRINTT enrols first 500 participants in frailty study

IMI’s SPRINTT project has enrolled the first 500 participants in a pan-European study on whether it is possible to prevent physical disability in older people with physical frailty and sarcopenia (loss of muscle mass and strength).### The study, which should eventually recruit 1 500 participants over the age of 70 from across Europe, will compare two interventions. Some participants will follow a multi-component programme, based on exercise with a trainer plus a nutritional programme. Others will follow a healthy ageing lifestyle education programme. More information on the trial can be found on the project website.

Participants

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EFPIA companies
  • Astellas Pharma Europe BV, Leiden, Netherlands
  • Biophytis SA, Paris, France
  • Boehringer Ingelheim Internationalgmbh, Ingelheim, Germany
  • Glaxosmithkline Research And Development LTD., Brentford, Middlesex, United Kingdom
  • Institut De Recherches Internationales Servier Iris, Suresnes, France
  • Novartis Pharma AG, Basel, Switzerland
  • Sanofi-Aventis Recherche & Developpement, Chilly Mazarin, France
Universities, research organisations, public bodies, non-profit groups
  • Aston University, Birmingham, United Kingdom
  • Centre Hospitalier Universitaire De Toulouse, Toulouse Cedex 09, France
  • Diabetes Frail Limited, Droitwich, United Kingdom
  • Friedrich-Alexander-Universitaet Erlangen-Nuernberg, Erlangen, Germany
  • Haskoli Islands, Reykjavik, Iceland
  • Medizinische Universitat Graz, Graz, Austria
  • Universita Cattolica Del Sacro Cuore, Milan, Italy
  • Universita Degli Studi Di Firenze, Florence, Italy
  • Universita Degli Studi Di Parma, Parma, Italy
  • Universitaetsmedizin Goettingen - Georg-August-Universitaet Goettingen - Stiftung Oeffentlichen Rechts, Goettingen, Germany
  • Universite Paris Descartes, Paris , France
  • Universiteit Maastricht, Maastricht, Netherlands
  • University of Helsinki, University of Helsinki, Helsinki, Finland
  • Univerzita Karlova, Prague 1, Czech Republic
  • Uniwersytet Jagiellonski, Krakow, Poland
Small and medium-sized enterprises (SMEs)
  • Caretek SRL, Torino, Italy
  • Eu-Open SRL, veronella (Vr), Italy
  • Roessingh Research And Development BV, Enschede, Netherlands
Third parties
  • Centre hospitalier universitaire de Limoges, Limoges, France
  • Institut National De La Sante Et De La Recherche Medicale, Paris, France
Non EFPIA companies
  • Istituto Nazionale Di Riposo E Cura Per Anziani Inrca, Ancona, Italy
  • Servicio Madrileno De Salud, Madrid, Spain

Participants
NameIHI funding in €
Aston University76 892
Caretek SRL2 522 000
Centre Hospitalier Universitaire De Toulouse1 461 521
Diabetes Frail Limited1 100 000
Eu-Open SRL560 411
Friedrich-Alexander-Universitaet Erlangen-Nuernberg1 462 794
Haskoli Islands349 650
Istituto Nazionale Di Riposo E Cura Per Anziani Inrca1 670 125
Medizinische Universitat Graz352 050
Roessingh Research And Development BV200 046
Servicio Madrileno De Salud2 146 723
Universita Cattolica Del Sacro Cuore4 623 897
Universita Degli Studi Di Firenze253 290
Universita Degli Studi Di Parma730 000
Universitaetsmedizin Goettingen - Georg-August-Universitaet Goettingen - Stiftung Oeffentlichen Rechts1 513 500
Universite Paris Descartes368 980
Universiteit Maastricht704 088
University of Helsinki1 492 749
Univerzita Karlova757 192
Uniwersytet Jagiellonski867 536
 
Third parties
NameFunding in €
Centre hospitalier universitaire de Limoges522 746
Institut National De La Sante Et De La Recherche Medicale263 249
 
Total Cost23 999 439